July 9, 2015 – Today, the Biosimilars Forum expressed grave concern in the proposed rule issued by the Center for Medicare and Medicaid Services (CMS) regarding biosimilar payment issued yesterday. As currently written, it is proposing that multiple biosimilars to the same reference product be grouped and issued the same J-code for Medicare reimbursement purposes.

“The biosimilars statute, and its legislative history, make clear that each biosimilar product — including multiple biosimilar products associated with the same originally marketed product — should be assigned a unique HCPCS code,” said Michael Werner, Biosimilars Forum policy advisor. “This is crucial toward establishing and maintaining a vibrant biosimilars market in the U.S.”

The lawmakers who passed the Biologics Price Competition and Innovation Act of 2009 (BPCIA) understood that biosimilars are not the same as generic drugs and should not be treated that way in policy making. This is also evident in the multi-tiered system of biologics and biosimilars, with interchangeable and non-interchangeable biosimilars, and the potential for multiple different reference biologics within a therapy as well as the possibility that multiple biosimilars to a single reference product may not share all indications. Furthermore, the statute makes it clear that an interchangeability determination only applies to a specific biosimilar and the reference product, and does not apply between or among multiple biosimilars approved to a single reference product. Issuing unique HCPCS codes is essential to avoid confusion among healthcare professionals, to ensure that the proper products are dispensed to patients, and to allow a fair and predictable reimbursement to purchasers of biosimilars.

Unfortunately, this proposal would lead to confusion in each of these areas. If finalized as written, this policy could materially reduce investment in development of biosimilars and thereby reduce treatment options available to patients. The law, legislative history, and biosimilar science support the requirement that CMS assign each biosimilar biological product a unique HCPCS code and not consider biologics and biosimilars in the same fashion as generic drugs.

“The Biosimilars Forum plans to respond to the proposed rule by September 8th, when the public comment period closes. We look forward to working closely with CMS and policy makers to correct the proposed regulation to reflect the BPCIA’s biosimilar payment and coding requirements,” said Werner.

The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.